There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This phase 1 open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CHS-006 in combination with toripalimab in 2 phases. Phase 1 (Dose Optimization phase) will explore 2 different dose combinations in participants with advanced/metastatic solid tumors (except pancreatic) and Phase 2 (Indication-specific Expansion phase) will use one selected dose in specific tumor types (non-small cell lung cancer-non squamous [NSCLC-NS] and Hepatocellular carcinoma [HCC])
The purpose of this research study is to determine the influence of a regular yogic breathing practice on sleep, and to find out primarily if a regular practice of 8-week yogic breathing would enhance sleep quality as well as if it would improve participant's quality of life, and reduce existing stress. Study participants will be randomized into two arms for different breathing practices.
This study is a randomized controlled trial (RCT) that compares the effects of two different 12-month aerobic walking exercise programs on cognitive processing speed (CPS), brain MRI, and other functional outcomes in 32 adults with multiple sclerosis (MS) who are able to walk without an assistive device but demonstrate slowed CPS. Participants (N=32) will initially undergo screening via telephone, and after satisfying relevant inclusion/exclusion criteria, will provide informed consent, followed by a baseline assessment of CPS remotely via a HIPAA-compliant virtual platform (i.e., Zoom for Healthcare). This assessment will also serve as a screen for ensuring impaired CPS. Following this virtual session, participants will come into Kessler Foundation (KF) and complete a 3-hour baseline assessment (T0) that includes a relatively short battery of neuropsychological tests, a 40-minute MRI scan, tests of walking function, a short questionnaire packet, followed by cardiopulmonary exercise testing on a motor-driven treadmill. Following T0, participants will be randomly assigned into one of the two aerobic walking ET programs that are remotely-delivered and supported by KF research assistants. As the conditions are delivered and supported remotely by KF personnel, the exercise itself takes place in the home/community setting. Both conditions involve behavior coaching via Zoom for Healthcare. The experimental condition involves high-frequency, high-intensity aerobic walking ET that exceeds the published guidelines for physical activity for adults with MS (GEMS+). GEMS + initially involves 10 minutes of moderate intensity aerobic walking exercise for 3 days per week and progresses to upwards of 40 minutes of vigorous intensity aerobic walking exercise for 5 days per week by month 12. The comparison condition involves mild-to-moderate aerobic walking exercise training that approximates published guidelines (GEMS). GEMS initially involves 10 minutes of light intensity aerobic walking exercise for 2 days per week and progresses up to 30 minutes of moderate intensity aerobic walking exercise for 3 days per week. Both conditions further will be monitored based on Fitbit-measured steps per exercise session. Of note, the sample size will be enrolled using 2 overlapping waves (Wave 1 = 14 participants, Wave 2 = 18 participants), 3 months apart. Participants will return to KF at the mid-point (i.e., T6) and end-point (i.e., T12) of the 12-month intervention period to complete the same assessments as T0. The T6 and T12 outcomes will be administered by treatment-blinded research assistants.
Articulatory deficits are present in most speakers with dysarthria, which negatively impacts their speech intelligibility, yet little is known about the relationship between articulatory movement and speech intelligibility. This study will examine the relationship between articulation measures, both acoustic and kinematic, and their relationship to perceptual measures (i.e., speech intelligibility and articulation ratings) in 30 individuals with dysarthria secondary to Parkinson's disease and 30 neurologically healthy adults of the same age. The findings will have implications for behavioral management.
Cognitive frailty, characterized by the coexistence of physical frailty and cognitive impairment, is a robust indicator of cognitive decline. Recognizing its significance, the International Association of Gerontology and Geriatrics and the International Academy on Nutrition and Aging have advocated for the use of cognitive frailty assessment as a means of monitoring the progression of mild cognitive impairment towards debilitating conditions like dementia, Alzheimer's disease, and loss of independence. Despite the clear need, a practical and remotely accessible tool for measuring cognitive frailty is currently lacking, especially within the context of telehealth visits. With telehealth video-conferencing becoming increasingly popular, accepted by healthcare payers, and preferred by older adults who may face difficulties traveling to a clinic, there is a pressing need for a software-based solution for remote cognitive frailty assessment that can be easily integrated into existing telehealth systems. This study proposes designing and validating a video-based solution to remotely monitor cognitive-frailty in older adults.
This is a prospective observational clinical trial to evaluate the clinical performance of the Cerec Tessera prosthetic assembly on implants restored with chairside CAD/CAM-generated crowns. This investigation is intended as a Post Market Clinical Follow-up study for the product Cerec Tessera and its prosthetic assembly for implants, which will serve as a life-cycle approach to safety, backed up by clinical data and post-market monitoring.
The goal of this clinical trial is to learn more about and compare the effectiveness of standard of care (SOC) physical therapy (PT), PT with photobiomodulation therapy (PBMT; low-level laser therapy), PT with shockwave therapy (SWT; high-energy acoustic wave therapy), and PT with PBMT and SWT, to improve function, decrease pain, and resolve symptoms in individuals with non-insertional Achilles tendinopathy. The main question it aims to answer is: • What is the most effective treatment method for non-insertional Achilles tendinopathy? Participants will Researchers will compare PT, PT + SWT, PT + SWT and PBMT to assess the most effective treatment for Achilles tendinopathy.
An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.
The goal of this double blinded clinical trial is to determine whether consumption of the PreforPro product, when co-consumed with Bacillus subtilis DE111 probiotic, synergistically improves bowel regularity, perceived physical symptoms of gastrointestinal distress and other aspects of gastrointestinal health over probiotic use alone. Therefore, the primary goal of this study is to see if PreforPro consumption concurrent with B. subtilis DE111 usage improves probiotic activity. The secondary goal of this study is to assess non-gastrointestinal physiologic parameters to determine whether consumption of PreforPro combined with the probiotic offers any additional health benefits (ie. reduced inflammation, improved gut microbiota profiles) beyond those of consuming a probiotic alone. Participants will be asked to track daily bowel movements for 7 days prior to beginning capsule consumption and record their diet for a total 3 of days (two weekdays and one weekend day). They will then be asked to consume the provided capsules daily for a period of 45 days. Researchers will compare three parallel arms; (1) PreforPro+B. subtilis DE111 probiotic, (2) B. subtilis DE111 alone, or (3) a maltodextrin placebo to establish their impact on gastrointestinal symptoms and other indicators of health.
Family caregivers for persons with dementia report high levels of depression, stress, and burden. Caregivers' limited time, transportation constraints, and unpredictable schedules make on-line, self-guided interventions more accessible and scalable. Acceptance and Commitment Therapy (ACT) is an established and effective in-person therapy, well-suited to the dementia care giving context where caregivers cannot minimize stress exposure, and report difficult thoughts and emotions. ACT for Caregivers is an on-line self-guided ACT intervention that showed effectiveness in a Stage I pilot (n=52) with participants reporting decreased depressive symptoms, stressful reactions to caring, and caregiver burden, and increased quality of life and positive aspects of caring (all p <.05). Learning from the pilot, the current Stage III intervention will shorten the program from 10 sessions to 6 sessions. The investigators introduce a wait list randomized control trial (RCT) design with fully longitudinal mixed methods to evaluate ACT for Caregivers. Data will be collected at pretest, post-test, and 6-weeks follow-up. Study aims are: 1) to evaluate ACT for Caregivers in a larger sample using an RCT, 2) to understand user experiences and the process of change by collecting short response data from all participants at all time points and interviewing a subset of participants in-depth at two time points, 3) to integrate quantitative and qualitative findings and examine areas of convergence and divergence. This project offers a promising prevention and intervention program to support family caregivers that is scalable, at low cost and with high impact.